Use of Dexmedetomidine for Sedation During Flexible Bronchoscopy in Patients With COPD: A Descriptive Study

2014-07-23 21:34:40 | BioPortfolio


To determine safety and effectiveness of dexmedetomidine when administered for conscious sedation during flexible bronchoscopy (FB) in patients with Chronic Obstructive pulmonary Disease (COPD).


This is a pilot study designed to provide preliminary data on the use of dexmedetomidine for outpatient FB procedures requiring sedation. Clinical parameters such as vital signs, level of sedation, dosing and supplemental sedation, and measures of comfort will be evaluated in a population of patients with known Chronic Obstructive Lung Disease undergoing elective FB.

Patients with COPD scheduled for outpatient FB will be provided with an intravenous infusion of dexmedetomidine (1 mcg/kg/hr) (Precedex®: Hospira, Inc, Lake Forest, IL) over a 15-30 min period before the procedure and continued throughout the procedure. No loading dose will be used prior to start of infusion. The FB procedure will be conducted according to standard practice using routine monitoring technique.

This dosing regimen of 1.0 mcg/kg/hr was chosen because the loading dose will be omitted and since a previous review have documented a lack of adverse events with maintenance doses exceeding 1 mcg/kg/hr.

Drug infusion will be discontinued if any of the following adverse events are observed: recurrent apnea (Respiratory Rate <7) lasting more than 30 seconds over a 5 min observation period, sustained episodes (30 seconds) hemoglobin oxygen saturation lower than 90% over a 5 min observation period, decrease of heart rate to below 50 beats/min, mean arterial pressure below 70% of its initial value.

If needed, additional sedation will be provided with alternating doses of midazolam 1 mg, or Fentanyl 25 mcg for pain, agitation interfering with the completion of the procedure, or for persistent cough non-responsive to local lidocaine instillation. The amount of Fentanyl and versed used as an adjunct for conscious sedation will also be recorded as part of this study.

The quality of sedation will be assessed using the Richmond Agitation Sedation Scale. The quality of analgesia will be assessed using the 11-point (0-10) Numerical Pain Rating scale (NRS). The level of recovery from anesthesia and the return of psychomotor fitness will be assessed using the Modified Post anesthesia Discharge Scoring System (MPADSS). The duration of FB and the time from the end of the procedure to the patient reaching a score of 9 and 10 on the MPADSS (readiness for discharge) will also be measured.

Except for the measurements described above (NRS), no additional procedures will be performed for the purposes of this study.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment






Cooper University Hospital
New Jersey
United States




The Cooper Health System

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:34:40-0400

Clinical Trials [567 Associated Clinical Trials listed on BioPortfolio]

Dexmedetomidine Sedation With Third Molar Surgery

Intravenous sedation is used frequently for the relief of pain and anxiety associated with oral surgical procedures performed under local anesthesia. The purpose of this study is to learn ...

Dexmedetomidine for Postoperative Sedation in Patients Undergoing Repair of Thoracoabdominal Aortic Aneurysms

The primary objective of this study is to test the hypothesis that time on the ventilator and ICU length of stay will be shorter in TAA patients given postoperative sedation with dexmedeto...

The Efficacy and the Safety of Dexmedetomidine Sedation on the Pediatric Intensive Unit(PICU) Patients.

To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to the pediatric intensive care unit after surgery.

The ED50 of DEX for Providing Sedation in Different Female Age Group

Dexmedetomidine(DEX) could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects. Because of its minimal impact on the respirato...

Dexmedetomidine Versus Pentobarbital for Pediatric Procedural Sedation

The investigators believe dexmedetomidine will provide superior sedation with reduced side effects and reduced time to discharge compared with pentobarbital. The investigators have develo...

PubMed Articles [250 Associated PubMed Articles listed on BioPortfolio]

Median effective dose of intranasal dexmedetomidine sedation for transthoracic echocardiography in pediatric patients with noncyanotic congenital heart disease: An up-and-down sequential allocation trial.

Intranasal dexmedetomidine can provide adequate sedation during short procedures. However, previous literature investigating the single-dose use of intranasal dexmedetomidine for sedation during trans...

Dexmedetomidine Sedation for Paroxysmal Supraventricular Tachycardia Ablation Is Not Associated With Alteration of Arrhythmia Inducibility.

Dexmedetomidine (Dex) is an attractive agent for procedural sedation due to its unique pharmacodynamic profile, specifically affording predictable sedation without concurrent respiratory depression. H...

Effect of Dexmedetomidine on Lactate Clearance in Patients with Septic Shock: A Sub-Analysis of a Multicenter Randomized Controlled Trial.

Lactate clearance is useful to guide initial resuscitation of patients with septic shock. We conducted this study to evaluate whether dexmedetomidine increases lactate clearance in patients with septi...

Comparison of Intraoperative Sedation With Dexmedetomidine Versus Propofol on Acute Postoperative Pain in Total Knee Arthroplasty Under Spinal Anesthesia: A Randomized Trial.

In patients undergoing total knee arthroplasty under spinal anesthesia, we compared the postoperative analgesic effect of intraoperative sedation with dexmedetomidine versus propofol. We hypothesized ...

Alfaxalone anaesthesia in Lemur catta following dexmedetomidine-butorphanol-midazolam sedation.

To evaluate the clinical effects and quality of sedation, induction, maintenance and recovery in Lemur catta after dexmedetomidine-butorphanol-midazolam sedation and alfaxalone anaesthesia.

Medical and Biotech [MESH] Definitions

A selective inhibitor of RECEPTORS, ADRENERGIC ALPHA-2 that has analgesic and sedative properties. MEDETOMIDINE is the other racemic form.

An agonist of RECEPTORS, ADRENERGIC ALPHA-2 that is used in veterinary medicine for its analgesic and sedative properties. It is the racemate of DEXMEDETOMIDINE.

A phenothiazine derivative with histamine H1-blocking, antimuscarinic, and sedative properties. It is used as an antiallergic, in pruritus, for motion sickness and sedation, and also in animals.

A histamine H1 antagonist used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than PROMETHAZINE.

Drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposely following repeated painful stimulation. The ability to independently maintain ventilatory function may be impaired. (From: American Society of Anesthesiologists Practice Guidelines)

More From BioPortfolio on "Use of Dexmedetomidine for Sedation During Flexible Bronchoscopy in Patients With COPD: A Descriptive Study"

Quick Search


Relevant Topics

Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...

COPD (chronic obstructive pulmonary disease)
COPD (chronic obstructive pulmonary disease) is used for a number of conditions including chronic bronchitis and emphysema, which all  lead to the airways in the lungs becoming damaged and thus narrower,  making inhalation and exhalation harder...

Searches Linking to this Trial